FDA-Device2014-09-10Class I
LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO STAND COVER REINFORCED UF (1) BLADE SURGICAL #11 STAINLESS STEEL (1) DRAPE SHEET 41 " X 58" SMS UF (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) TUBE SUCTION CONNEC. 3/16" x 12' UF (3) TOWEL ABSORBENT 15" X 20" UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIWRAP (1) TABLE COVER REINFORCED 50" X 90" UF (2) GOWN LARGE SMS IMPERV. REINFORCED (4) DRAPE UTILITY WITH TAPE UF EO sterilized surgical convenient pac
Customed, Inc
Hazard
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Sold states
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Affected count
26 lots; 1412 units (multiple units per lot)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO STAND COVER REINFORCED UF (1) BLADE SURGICAL #11 STAINLESS STEEL (1) DRAPE SHEET 41 " X 58" SMS UF (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) TUBE SUCTION CONNEC. 3/16" x 12' UF (3) TOWEL ABSORBENT 15" X 20" UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIWRAP (1) TABLE COVER REINFORCED 50" X 90" UF (2) GOWN LARGE SMS IMPERV. REINFORCED (4) DRAPE UTILITY WITH TAPE UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2333-2014Don't want to check this manually?
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